CAR-T Cell Therapy for Desensitization in Kidney Transplantation

Kidney Failure Clinical Trial

Official title: Autologous Chimeric Antigen Receptor Engineered T Cell Immunotherapy for Desensitization in Patients Awaiting Kidney Transplantation

Status Recruiting

Clinical Trial Summary

This research study is for people who have been waiting for a kidney transplant for at least one year, and who have a cPRA of 99.5% or higher. Having a cPRA of 99.5% or higher means that your immune system would reject 99.5% of kidneys available for transplant. The study will test whether new products called Chimeric Antigen Receptor T Cells (CAR T Cells), when given with chemotherapy, is safe and will reduce cPRA.

The main study will last up to 2 years: Participants will have up to 30 clinic or hospital visits over a one-year period. If a transplant takes place, there will be 9 more visits after transplant. Long term follow up is required by the Food and Drug Administration (FDA) for 15 years after receiving CAR T cell.

The primary objective is to evaluate the safety and feasibility of administering CART BCMA + huCART-19 following lymphodepletion, including determination of optimal tolerated regimen (OTR) and/or recommended phase 2 regimen, according to the incidence of dose limiting toxicity (DLT) in highly sensitized patients awaiting kidney transplant.

Clinical Trial Description

CTOT-46 will enroll up to up to 20 highly sensitized kidney transplant candidates at 3 centers. There will be a safety run-in and 3 treatment cohorts to assess the safety and pharmacodynamics of CART-BCMA and huCART-19.

Following screening and enrollment, the subject will undergo leukapheresis to collect T cells for CAR T cell manufacturing. Subsequently, subjects will undergo lymphodepleting chemotherapy followed by CART-BCMA and huCART19 cell infusions. A secondary objective is to evaluate the efficacy of study treatment to reduce cPRA and determine the duration cPRA reduction. ;

Related Conditions & MeSH terms

• End Stage Renal Failure on Dialysis
• Kidney Failure
• Kidney Failure, Chronic
• Kidney Transplant
• Renal Insufficiency

• NCT number: NCT06056102
• Study type: Interventional
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: Mary Kaminski, PA
• Phone: 215-349-8334
• Email: mary.kaminski@pennmedicine.upenn.edu
• Status: Recruiting
• Phase: Phase 1
• Start date: May 9, 2024
• Completion date: December 15, 2042